GRAIL · 5 hours ago
Regulatory Affairs Associate Director, IVD # 4432
United States
Full-time
Remote
Lead/Staff, Director/Executive
$164K/yr - $205K/yr
10+ years expGRAIL is a healthcare company pioneering new technologies to advance early cancer detection. The role of Regulatory Affairs Associate Director involves assisting with regulatory strategy and the development of submissions for GRAIL projects while collaborating cross-functionally to support regulatory strategy development and compliance.
BiotechnologyHealth CareHealth DiagnosticsMedicalMedical Device
Responsibilities
Strategize, plan, and author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities
Support the U.S. Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings
Serve as a key member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies
Provide regulatory support for both new and marketed Laboratory Developed Test (LDT) products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval
Monitor and report on international regulatory developments and LDT requirements that may significantly impact business operations or customers
Maintain up-to-date knowledge of applicable regulatory requirements and relevant scientific/technical developments
Identify regulatory risks and propose alternative courses of action
Assess new regulations and collaborate with internal teams to implement appropriate changes
Support internal and external quality audits
Ensure compliance with all regulations and laws applicable to GRAIL's business, providing guidance and recommendations
Review and approve regulatory strategy documents, regulatory plans, procedures, SOPs, and other documents for alignment with commitments, regulations, and filings
Manage the creation and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department
Perform other duties as assigned
Qualification
Required
Minimum of 10 years of experience in regulatory, development, clinical affairs, quality, or program management within the IVD, medical device, or pharmaceutical industries
Direct experience with FDA regulatory submissions required
Demonstrated knowledge of U.S. and international regulatory frameworks and processes for medical device development and approvals
Proven leadership and sound judgment with strong business partnering skills
Effective collaborator in dynamic, fast-paced, and evolving environments
Problem-solving mindset with the ability to work well across diverse teams
Strong written and verbal communication skills
Excellent organizational skills and attention to detail
Preferred
Regulatory affairs and IVD device experience preferred
Experience with regulatory submissions in the EU, Japan, China, Canada, and other international markets is preferred
Background in diagnostics or biomarker development, particularly in oncology, is a plus
Advanced scientific degree preferred
Regulatory Affairs Certification (RAC) preferred
Experience in pharmaceutical clinical, statistical, or regulatory settings—especially in oncology, immunology, or related fields—is a plus
Benefits
Flexible time-off
A 401k with a company match
Medical, dental, vision plans
Carefully selected mindfulness offerings
Company
GRAIL
Grail is a healthcare company that develops pan-cancer screening tests designed to detect cancers at an early stage.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2.44BKey Investors
ARCH Venture PartnersIllumina
2025-10-20Post Ipo Equity· $325M
2025-10-16Post Ipo Equity· $110M
2024-06-13IPO
Leadership Team
Satnam Alag
Senior Vice President Software Engineering and Chief Security Officer
Joshua J. Ofman
President
Recent News
The Motley Fool
2026-01-23
2026-01-16
2026-01-14
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